Active Ingredient: Clascoterone
For this indication, competent medicine agencies globally authorize below treatments:
For:
Cutaneous, 1 spreads clascoterone, 2 times daily, over the duration of 3 months.
A thin uniform layer of cream should be applied to the affected area twice a day, in the morning and the evening, with at least eight hours between applications.
Approximately 1 g of cream will cover an area of about 28 x 22 cm (approximately 600 cm2 of skin, corresponding to the average surface area of the face).
Total daily dose should not exceed approximately 2 g of 10 mg/g clascoterone cream. The cream must be applied on the face only. No more than 60 g a month should be used.
To achieve the therapeutic effect, it is recommended to treat for three months. After three months of treatment, it is recommended that the physician evaluates the continued improvement of the patient. Thereafter, regular assessment every three months of the skin and of the status of the patient should determine if continued use of clascoterone is needed taking into account the status of the disease and the safety profile of the treatment.
In adolescents, the physician may decide to conduct the first evaluation visit earlier than three months, depending on the patient's adherence to treatment and/or safety considerations.
The affected areas should be clean and dry before application. Clascoterone should not be applied to cuts, abrasions, eczematous or sunburned skin. The cream must be applied without using occlusive dressing to avoid an increased risk for systemic undesirable effects.
Other cutaneous medicinal products used to treat other conditions on the same skin areas should be applied with a minimum of two (2) hours before or after the application of clascoterone cream. This is also applicable to the use of sunscreen or emollients.
The patient should be instructed to apply a thin, uniform layer of clascoterone cream to the affected area, massaging gently, avoiding the eyes, eyelids, lips and nostrils, and then wash hands after application. The cream must be applied to the entire affected area and not to the acne lesions only.
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